1. Field of the Invention
The present invention is in the field of devices used for incontinence management, and since it has structure that is free of the flaws commonly found in prior art incontinence management devices, the present invention both facilitates stool management and prevents the spread of disease that would otherwise be prevalent with discharge of infectious stool (such as c-diff, etc.) into a diaper. The flaws and disadvantages which have been consistently associated with prior art devices in the field of incontinence management are: 1) skin breakdown under the bandage component (known as channeling), and channeling requires a discontinuation of use of the device until the skin is healed; 2) devices becoming torn off while non-comatose patients move about in their beds, which often occurs and results in skin tears that can also require discontinuation of the device until the skin is healed; 3) lodging of semi-formed stool in the prior art devices, making them unusable and requires a discontinued use of the device even when infectious semi-formed stool is present; 4) a decrease in patient dignity and comfort when stool is deposited into a diaper; and 5) excoriation of patient skin and even more severe skin breakdown when the device is discontinued. Although several preferred embodiments are disclosed herein, the most preferred embodiments each have an absorbent insert ring component. (or equivalent) and an absorbent insert extension that alone or in combination with other structure directs stool into an associated stool collection bag (which can be configured to envelop the patient in the same manner as a diaper). Super Absorbent Polymer (hereinafter SAP) resin may also used as a part of the stool containment structure of the present invention, or non-toxic, non-irritating, non-corrosive, and super absorbent materials capable of absorbing forty-to-sixty times their weight in fluid (instead of the cellulose or other fiber-based products that only absorb approximately twenty times their weight in fluid). In addition, a stool collection bag used as a part of the present invention is typically secured in approximately the same area where an incontinence pad would be positioned to facilitate passage of formed stool, so that diarrhea can be contained from start to finish. For example, one preferred embodiment of the present invention employs at least one portion of a hook-and-loop fastener attached to its stool collection bag for help in securing an absorbent insert ring component against the area of the patient immediately around the anus (also hereinafter referred to as ‘rectal opening’). The absorbent insert ring component, in combination with any absorbent insert extension used therewith, prevent channeling. A preferred embodiment structured for female patients also employs at least one portion of a hook-and-loop fastener to secure the female outer flesh protrusion (the vulva-flaps) to a diaper in a manner that directs urine into the diaper and away from the patient's skin, while a preferred embodiment structured for male patients has a convenient lined opening that allows urine to be directed into a diaper as a collection bag where urine storage is away from patient skin. When waterproof seals are used as a part of the present invention, any diaper used with it is converted into a plastic stool and urine collection bag, sealing off urine, stool, and any associated odor that would otherwise be released from the bag. In this embodiment, the hook and loop portions of a hook-and-loop type of fastener are also connected together to provide structure that protects the wearer's body from contact with urine or stool. As a result, the diaper used as a part of the present invention is adapted to become a leak-proof, odor-proof, and waterproof collection bag.
2. Description of Related Art
The present invention is configured to reduce the spread of disease-bearing organisms in patients with diarrhea, and the breakdown of patient skin experienced in extended or repeat contact with liquid stool, by blocking channeling, which results from the leakage of liquid stool under bandages placed in close association with rectal opening to secure a prior art stool collection bag. Clostrium difficile (also referred to herein as C. difficile or c-diff) is a commonly-known bacterium that is currently being spread at alarming rates during patient care in U.S. hospitals and long-term care facilities, largely as a result of the overuse of certain antibiotics. Worldwide problems with c-diff infections also occur. C. difficile can cause diarrhea, as well as life-threatening inflammation or perforation of the colon. It is also a spore-releasing bacterium, and is resistant to some antibiotics. Alcohol-based hand sanitizers do not kill the dormant C. difficile spores, nor does hand washing with soap and water. In addition, special bleach cleansers are required to stop the spread of infection once C. difficile spores come into contact with other surfaces where they can survive for weeks or months. Also, once spores come into contact with hospital uniforms, bed linens, and diapers, the spores can travel widely throughout a hospital or long-term care facility, as only a long soaking in bleach will kill them. The number of c-cliff infections has increased significantly during the last 20-30 years due to the incomplete containment of diarrhea run-off, and recently became a leading healthcare-associated infection, surpassing the number of infections due to methicillin-resistant Staphylococcus aureus (MRSA).
Dealing with the cleanup of diarrhea in hospital and long-term care facilities is always time-consuming and expensive (often exceeding $4,000 per patient in hospital-acquired C. difficile) and has traditionally included diapers, creams, ointments, skin breakdown fixes such as sterile bandages and medications, and sufficient labor to keep the patient clean so that skin healing can occur. Prior art stool collection devices are currently allowed to stay in place for a maximum time period of only twenty-four hours, and they are removed more frequently should stool leakage occur, as repeat or extended contact with liquid stool quickly causes skin breakdown. Also, the channeling of diarrhea under a bandage that holds a stool collector in place and subsequent breakdown of patient skin, leads to subsequent discontinuation of the stool collection device, resulting in the increased opportunity for spread of c-diff infection to others. Annual diaper cost for one hundred patients with diarrhea is estimated at more than $200,000, and the annual cost of creams for one hundred diarrhea patients may add another $20,000. Staff labor costs for those same one hundred patients may approach $1 million, with disposal cost for used diapers estimated at approximately $32,000. Thus, the estimated cost of treating one hundred diarrhea patients is approximately $1.25 million per year. It is estimated that on any given day in U.S. hospitals more than 7,000 patients have a c-diff infection, leading to more than 500,000 people infected in U.S. hospitals with C. difficile annually. Thus, the treatment costs of hospital-acquired or nursing home-onset of diarrhea in the U.S. as a result of c-diff infection is now estimated to be approximately a $3-6 billion annual expense. It is also estimated that one-third of patients with a C. difficile diagnosis return to a hospital with a recurrence of the disease. Since the present invention prevents channeling (that leads to skin break and discontinuation of prior art stool collection devices), use of the present invention would break the chain of infection and slow down or stop the current C. difficile epidemic (which cause approximately 32,000 deaths in the United States each year), and would also significantly reduce the high cost currently experienced by hospitals and long-term care facilities for the treatment of c-diff infections. In addition, if a patient gets a hospital-acquired c-diff infection, the hospital then becomes responsible for the cost of hospital care for the remainder of the patient's stay. In addition, if the patient has a recurrence of c-diff, on the patient's return, the hospital is also responsible for the cost/expenses for the return visit.
Another difficulty in the use of prior art stool collectors (which is overcome by present invention use), is that its positioning is on the backside of a patient in bed, and when a patient slides down, the bandage adhering the stool collector to the patient's skin pulls off, often tearing the skin. Another deficiency in prior art stool collectors, is that as a patient with serious diarrhea heals, the diarrhea gradually turns into a formed stool which can get stuck in the opening of a stool collector, making prior art stool collectors dysfunctional and necessitating their removal from the patient for the remainder of the patient's recovery. The present invention offers solutions that overcome all of these deficiencies. No invention is known that has the same features as the present invention, its same structure, or provides the same benefits and advantages to a user as the present invention.